Ankle ulcer sleeve to prevent ankle ulcers from venous insufficiency

Abstract

An ankle ulcer sleeve for treating and preventing ankle ulcers due to venous insufficiency and specifically for use after varicose vein procedures, such as venous vein ablation is described. The ankle ulcer sleeve includes a compression component extending on a medial side of the ankle extension of the ankle ulcer sleeve to provide compression on ankle perforator veins and cause them to collapse after a varicose vein procedure to prevent ulcers from forming.

Description

Docket No.: ITP / 1007PCTANKLE ULCER SLEEVE TO PREVENT ANKLE ULCERS FROM VENOUS INSUFFICIENCY BACKGROUND OF THE INVENTIONField of the Invention

[0001] The invention relates to an ankle ulcer sleeve for treating and preventing ankle ulcers due to venous insufficiency and specifically for use after varicose vein procedures, such as venous vein ablation.Background

[0002] Ankle perforator veins are short veins that connect superficial veins to deep veins in the ankle region. Ankle perforator veins extend between the saphenous vein and the femoral vein, or more specifically from the posterior arch vein, extending from the saphenous vein to the lateral plantar vein that extend to the femoral vein. The ankle perforators include the posterior tibial perforator veins. Perforator veins more proximal to the heart and in the lower leg include the Crockett’s perforators in the lower calf region. The ankle perforator veins are highly susceptible to venous insufficiency. Perforator veins have valves that prevent blood from flowing backwards from the deep to the superficial veins. However, when these valves fail to function properly, increased pressure in the superficial veins, can occur leading to skin and tissue damage and leg ulcers. These ankle ulcers are chronic and will not heal without intervention.

[0003] From “TheUltimateVeinGuide.co ”:

[0004] “Perforator venous insufficiency, also known as incompetent perforators, occurs when the valves in the perforator veins malfunction. This leads to reflux, otherwise known as reversal of blood from the deep venous system to the superficial venous system. One cause of perforator venous insufficiency is the weakness of the perforator veins at the juncture where the perforator veins connect with the superficial veins known as re-entry points. This results in the dilatation of the perforator veins which eventually leads to reflux.

[0005] Signs and Symptoms of Perforator Vein Insufficiency

[0006] Symptoms of perforator venous insufficiency often vary depending on its location and the severity of perforator vein incompetence. Some of these features are:

[0007] Varicose veins are large bluish swollen veins that occur around the legs and feet. They are painless unless complications arise. A characteristic of varicose veins due to perforator vein insufficiency is that the varicosities recur after treatment so long as the underlying condition persistsDocket No.: ITP / 1007PCT

[0008] Leg ulcers are open wounds that occur around the ankles. Increased pressure in the superficial veins secondary to incompetent perforators results in skin and tissue damage leading to the development of leg ulcers. These leg ulcers are chronic and non-healing as long as the underlying condition is not corrected.

[0009] Edema is caused by a backflow of blood into the lower limb and superficial veins that results in blood pooling in the legs and feet. This forces fluid out of the blood vessels and into the surrounding tissues, resulting in swelling, otherwise known as edema. In fact, this swelling is called “pitting edema" because indentation marks are left when pressure is applied over the swelling.

[0010] Skin discoloration occurs around the ankles and is due to venous insufficiency.

[0011] Leg pain is triggered by walking or running and is relieved by rest. Sometimes, painful leg cramps may randomly occur. Both types of pain are due to poor circulation in the lower limbs.

[0012] Varicose vein procedures are very common and often ablate and / or collapse the saphenous vein but do not treat the perforator veins. With these perforator veins open to blood flow from the femoral vein, ulcers can form.SUMMARY OF THE INVENTION

[0013] The invention is directed to an ankle ulcer sleeve, a compression sleeve for treating and preventing ankle ulcers due to venous insufficiency and specifically for use after varicose vein procedures, such as venous vein ablation. An exemplary ankle ulcer sleeve comprises an ankle extension, a sleeve that is configured to extend over and around an ankle of a person and may also have a heel portion configured to extend over a person’s heel and may also have a foot extension configured to extend over a person’s foot and may have an open end wherein the person’s toes are exposed or a closed end wherein the foot extension encloses a person’s foot to form a sock. An ankle ulcer sleeve forms a cylindrical sleeve around a person’s ankle and may extend over the heel and over a portion of the foot.

[0014] The ankle extension extends over the ankle perforator veins and is configured to apply pressure to the ankle perforator veins, which are along a medial side of a person's ankle. The ankle extension also applies pressure around the ankle and this may aid in preventing ulcers around the ankle including on the lateral side, which can occur but are less common. The ankle extension may extend along a gaiter region of the leg, which in medicine refers to the lower part of the leg, from the mid-calf down to just above the ankle. The gaiter region is the area of the leg where ulcers from venous insufficiency form, often showing discoloration, hardening (lipodermatosclerosis), and swelling.Docket No.: ITP / 1007PCT

[0015] The ankle extension has a length from an inferior end to a superior end and is configured to extend over the ankle perforator veins so the length may be about 12.5cm or more, about 15cm or more, about 20cm or more or even about 30cm or more, or no more than 40cm or no more than 35cm, and any range between and including the lengths provided. The length of the ankle extension when the ankle ulcer sleeve includes a heel portion is measured from the medial malleolus protrusion to the superior end of the ankle extension. The ankle extension has a lateral ankle portion, a medial ankle portion, anterior ankle portion and a posterior ankle portion. These portions are length extensions around the circumference of the ankle extension of the ankle ulcer sleeve.

[0016] The ankle ulcer sleeve or ankle extension thereof, has a compression component extending along the medial ankle portion of the ankle extension. The medial compression component has a thickness that is at least 50% greater than, or at least 100% greater than the ankle extension portions, or ankle extension without a compression component. The ankle extension may be a fabric that includes the compression component extending only around a portion of the circumference of the ankle extension. This localized circumferential extension of the compression component produces higher compression force along the compression component than the rest of the ankle extension and this is important to focus compression over the medial side of the ankle to prevent blood flow into the ankle perforators.

[0017] The compression component may only extend a portion of the interior circumference of the ankle extension, such as no more than about 50%, no more than 35%, no more than 30%, no more than 25%, no more than 20% of the interior circumference of the ankle extension. The compression component may extend partially into the anterior ankle portion and / or posterior ankle portion but does not extend into around the ankle extension to the anterior ankle portion.

[0018] The ankle extension may be radially elastic, wherein the diameter of the ankle extension can be increased or enlarged to slide the ankle ulcer sleeve over a person’s foot and onto their ankle and wherein it will rebound to an original shape when removed. The ankle extension may be stretched radially 50% or more, 75% or more, or even 100% radially, wherein the diameter is increased a percentage and will return to an original diameter when the stretching force is removed, thereby being radially elastic. The cylindrical ankle sleeve may produce a radial compression pressure when donned to prevent ulcers and this pressure when stretched 20% radially or having a 20% radial extension, may be about 8 to 15mm Hg or more for mild compression, about 12 to 20mm Hg or more for moderate compression, and about 20 to 30mm Hg for firm compression and extra firm compression may be 30 to 40mm Hg or more. A 20% radial extension means theDocket No.: ITP / 1007PCTcircumference of the ankle extension is increased 20% over the unstretched circumference of the ankle extension.

[0019] The pressure required to effectively collapse a vein or perforator may be about 25mm Hg or more, about 30mm Hg or more, about 40mm Hg or more and any range between and including the values provided. A preferred range may be 20mm to 30mmHg as this may be a sufficient pressure to collapse the veins and perforators without blocking blood flow to the foot.

[0020] The compression component may be an elastomeric material such as a urethane or silicone, for example. An elastic compression component may conform better to anatomical features of the ankle and provide uniform pressure over the medial side of the ankle to compress the ankle perforator veins and prevent ulcers. The compression component may have a three-dimensional shape with a thickness extending from the interior of the ankle extension that may conform with the curvature of the ankle, especially the curvature around the medial malleolus.

[0021] Historically compression therapy is delivered by woven, 2-dimentional, elastic fabrics. This two dimensional format prevents a good conformal fit over areas that are not flat, such as regions near the medial malleolus. The ankle ulcer sleeve incorporates a compression component that forms a 3-dimensional extension from the ankle extension that will provide improved conformation and thereby provide for proper pressure levels.

[0022] The compression component may extend the full length of the ankle extension or a portion of the length. The ankle ulcer sleeve may include a medial compression component configured on the medial ankle portion of the ankle extension and / or a lateral compression component configured on the lateral ankle portion of the ankle extension. The ankle extension and / or the medial or lateral compression component may be configured to extend along the ankle and lower leg above the medial malleolus, or lateral malleolus, respectively, toward the knee a length of about 12.5cm or more, about 15cm or more, about 17.5cm or more or even about 20cm or more, and any range between and including the lengths provided. A length of 20cm would cover the lower perforators.

[0023] The medial compression component may extend around the medial malleolus and may have a width effectively large to cover the veins and perforators that are posterior and anterior to the medial malleolus on the medial side of the ankle, such as about. The medial compression component may have a width extending posterior from the medial malleolus or along the posterior ankle extension that is at least 8cm, at least 10cm, at least 12.5cm, at least 15cm and any range between and including the width values provided. The vast majority of perforators that may require compression to prevent ulcers are located within 4cm posterior from the medial malleolus and within 20cm superior or above the medial malleolus and therefore a posterior ankle extension of the compression component has aDocket No.: ITP / 1007PCTwidth of about 4cm or less and length of about 20cm or less to ensure compression over the most critical area for preventing ulcers from venous insufficiency.

[0024] The lateral compression component may also have a width of at least 8cm, at least 10cm, at least 12.5cm, at least 15cm and any range between and including the width values provided and this width may be the width of the posterior ankle extension that extends toward the knee, posterior from the lateral malleolus.

[0025] The thickness of the compression component (medial and / or lateral) may vary, and the inside surface may be contoured to produce increased pressure on the veins and perforators and may have a contoured surface configured to match the general anatomical contours around the medial malleolus. A medial compression component may extend around the medial malleolus and may have a medial malleolus recess, a portion of the medial compression component that is much thinner than a posterior portion and / or anterior portion of the medial compression component from the medial malleolus, such as less than 75% of the thickness, less than 50% of the thickness or even less than 25% of the thickness of the posterior portion and / or anterior portion of the medial compression component. A medial malleolus recess may have a concave shape to accommodate and conform to the convex shape of the medial malleolus shaped protrusion. Likewise, a lateral compression component may extend on the lateral side of the ankle extension and may also have a thickness that varies and may have a lateral malleolus recess, a portion of the lateral compression component that is much thinner than a posterior portion and / or anterior portion of the lateral compression component from the lateral malleolus, such as less than 75% of the thickness, less than 50% of the thickness or even less than 25% of the thickness of the posterior portion and / or anterior portion of the lateral compression component. A lateral malleolus recess may have a concave shape to accommodate and conform to the convex shape of the medial malleolus shaped protrusion. The thickness of a compression component may be about 2mm or more, about 4mm or more, about 6mm or more, about 8mm or more, or even 10 or 12mm or more and any range between and including the thickness values provided.

[0026] The ankle ulcer sleeve may be a contiguous sleeve wherein the fabric is contiguous about the circumference of the ankle ulcer sleeve or it may include a detachable seam, wherein the ankle ulcer sleeve is wrapped around a person's leg and then detachably attached, wherein a first side is pulled over a second side and attached by an attachment, such as clips, or hook-and-loop fasteners and the like.

[0027] The invention includes a method of treating venous insufficiency including, treating varicose veins, such as the saphenous vein by venous ablation, including chemical ablation, radiofrequency ablation, laser ablation and / or removal of varicose veins surgically, followed by application of the ankle ulcer sleeve over the ankle after the treatment of the varicoseDocket No.: ITP / 1007PCTveins. The ankle ulcer sleeve will compress the perforator veins including the ankle perforators or any other perforator veins configured below the calf. The ankle ulcer sleeve may only extend up a portion of the person’s leg, such as about 20cm or less, about 17.5cm or less, about 15cm or less or even 12.5cm or less. Application of pressure just along the lower less or ankle region may be more effective than a sleeve that extends further up the leg and over the calf or a portion of the calf.

[0028] An ankle ulcer sleeve may include a compression component that has a particular shape to provide improved compression and comfort. The compression component may extend around the medial malleolus the protrusion on the medial side of the ankle. The compression component may have a medial ankle extension and a posterior ankle extension that extend around the medial malleolus. The medial ankle extension and a posterior ankle extension may be separate components or may be connected along a connected portion that is on a posterior side of the medial malleolus. The compression component may have a curved edge along the anterior side of the connected portion for conforming around the medial malleolus protrusion. Note that a compression component may also be configured for placement on the lateral side of the ankle, as ulcers can also form on the lateral side.

[0029] The length of the posterior ankle extension may be about 10cm or more, about 12cm or more, about 15cm or more, about 20cm or more and any range between and including the values provided. The width of the posterior ankle extension may be a fraction of the length, such as about 0.75 the length or less, about 0.5 the length or less. Also, the width may change along the length of the posterior ankle extension and may increase from a connected portion to the extended end. The width of the posterior ankle extension at the extended end or proximal to the extended end may be much greater than the width proximal to the connected portion or on the opposing extended end, such as about 1.5 times or more, about 1.75 times or more, about 2.0 times or more and any range between and including the ratios provided. This geometry of the posterior ankle extension may provide better compression over some of the perforators. The posterior ankle extension may be effectively wide to cover the ankle perforator veins, which are along a medial side of a person’s ankle, such as about 2.5cm or more, about 3.0cm or more, about 3.5cm or more, about 4.0cm or more, about 5cm or more and any range between and including the width values provided. The superior end of the posterior ankle extension may be wider than the width of the posterior ankle extension proximal to the medial malleolus.

[0030] The medial ankle extension has a length from the connected portion or first end to an extended end that may be about 10cm or more, about 8cm or more, about 6cm or more, about 4cm or more and any range between and including the values provided and a width that may be about 8cm or more, about 6cm or more, about 4cm or more, about 2cm or more and any range between and including the values provided. The interior or anterior edge ofDocket No.: ITP / 1007PCTthe compression component along the connected portion may provide a space for the medial malleolus and may better retain the ankle ulcer sleeve in position and provide improved compression over the perforators to prevent ankle ulcers.

[0031] The compression component may have a hockey stick shape, wherein a length axis of the posterior ankle extension extends substantially orthogonal to a length axis of the medial ankle extension within about 30 degrees of orthogonal and preferably with about 20 degrees of orthogonal. The posterior ankle extension may extend along a portion of the inner circumference of the ankle ulcer sleeve, such as no more

[0032] The thickness of the compression component, such as an elastomeric material may be about 4mm or more, about 6mm or more, about 8mm or more, about 10mm or more, or even about 20mm or more. The shaped geometry of the compression component around the medial malleolus protrusion may increase compression in the desired areas to prevent ankle ulcers.

[0033] A compression component may have protrusions extending from the inside or contact surface that aid in allowing blood flow along the compression component and also air circulation. The protrusions may be discrete protrusions or elongated protrusions that form ribs extending across a portion of the compression component or from a first edge to a second edge of the compression component to allow airflow between the compression component and a person’s skin or fabric configured therebetween. Also, a compression component may include apertures to also aid in blood flow and air circulation to the skin and tissue under the compression component.

[0034] A compression component may have protrusions extending from an inside surface to promote air exchange to prevent heat and discomfort. A protrusion may be a discrete protrusion, dots for example, or an elongated protrusion having a length that is at least three times a width of the protrusion. A protrusion may extend from a first edge to a second edge of a compression component and such as from a superior edge to an inferior edge.

[0035] A method of making an ankle ulcer sleeve may include scanning a person’s ankle to determine an ankle geometry and then fabricating a compression component having a compression geometry that conforms to said ankle geometry. A compression geometry may have a concave shape in a medial malleolus recess for conforming around the medial malleolus and a convex shape inferior to the medial malleolus recess to ensure proper pressure for collapsing veins and perforators. The method may further comprise attaching the compression component to the ankle ulcer sleeve, however the compression component and ankle ulcer sleeve may be an integral part, being made through molding or three-dimensional printing, for example. A compression component and ankle ulcer sleeve may include strands of material, such as elastomeric material, that are interconnected at nodes to form a lattice. These strands may be tapes and have a rectangular cross-sectional shape,Docket No.: ITP / 1007PCTor may have circular or oval cross-sectional shape, or may have a more complex shape, an irregular cross-sectional shape that is designed to produce desired compression and stiffness, including but not limited to tetrahedral, icosahedral, Kagome, voronal and rhombic cross sectional shapes. The compression and stiffness may vary over the compression component and / or the ankle extension of the ankle ulcer sleeve. The compression component or components and the ankle extension may be formed separately and later combined or may be formed integrally, wherein the compression component forms a portion of the ankle sleeve, and wherein the compression component and ankle sleeve are a one-piece unit or monolithic part. The medial and lateral compression components may be fabricated by molding or three-dimensional printing to match a measured shape of the anatomy of a person’s ankle. The compression component may be an elastomer that is configured to exert a compression force onto a person’s ankle to block flow through veins and perforators.

[0036] A method of compressing a perforator in a person’s ankle may include first measuring a collapsing pressure, a pressure required to block blood flow through said vein or perforator. This force may be measured through use of a pressure sensor and an ultrasound to determine blood flow through a vein or perforator. Pressure may be increased and when blood flow is stopped or effectively slowed, as indicated by the ultrasound, the pressure measured may be an effective collapsing pressure. This analysis may be conducted via a pressure sensor that is separate from the ultrasound, or a pressure sensor may be coupled to an ultrasound probe, whereby the ultrasound pressure device may be pressed against the person’s skin and when the blood flow is stopped, the pressure may be recorded as the collapsing pressure. The force may be measured and the pressure calculated by the area of contact of the probe and this calculation may be part of the probe, wherein the pressure is displayed or reported or this may be calculated manually from a force measurement.

[0037] A compression component may be made that has a thickness to effectively apply a collapsing pressure when donned over the person's ankle via the ankle ulcer sleeve. As described herein, the compression component may be a custom compression component that has a compression surface that matches the ankle contour surface. This custom surface interface between the compression component and the ankle surface may much more effectively block blood flow through the veins and perforators and prevent ulcers from forming.

[0038] Compression therapy for people with venous insufficiency is predicated on applying a known pressure to prevent edema, the formation and / or the return of ankle ulcers. The method described herein includes measurement of the actual pressure values in situ with the ankle ulcer sleeve donned over a person’s ankle. The geometry of the ankle around theDocket No.: ITP / 1007PCTmedial malleolus makes predicting pressure applied here via a compression rating of a compression garment, such as an ankle sleeve difficult. Because this area of the ankle has concave curvature, often the pressure applied via a compression sock or sleeve is much less than stated on the garment and therefore insufficient pressure is applied where it is needed most, in the concave area under and around the medial malleolus. Ankles are not uniform in geometry, they are not perfect cylinders. Therefore, the method described herein, includes measuring actual collapse pressures for targeted veins (the information upon which a compression therapy prescription should be based) and then verifying that the prescribed pressure is achieved once the compression sleeve is donned by the patient.

[0039] The summary of the invention is provided as a general introduction to some of the embodiments of the invention and is not intended to be limiting. Additional example embodiments including variations and alternative configurations of the invention are provided herein.BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

[0040] The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and together with the description serve to explain the principles of the invention.

[0041] Figure 1 shows a picture of a person's ankle with ankle ulcers due to venous insufficiency.

[0042] Figure 2 shows a diagram of the lower leg, ankle and foot and perforator veins.

[0043] Figure 3 shows a diagram of the lower leg, ankle and foot and perforator veins.

[0044] Figure 4 shows a diagram of the lower leg vascular system and ankle perforator veins.

[0045] Figure 5 shows a person’s foot, ankle and the medial malleolus protrusion protruding from the interior or medial side of the ankle.

[0046] Figure 6 shows the person’s foot and ankle from FIG. 5, with an ankle ulcer sleeve configured over the ankle and having an ankle extension with a compression component configured along the medial side of the ankle and lower leg.

[0047] Figure 7 shows an ankle ulcer sleeve having an ankle extension, a heel portion and a foot extension with an open end.

[0048] Figure 8 shows an ankle ulcer sleeve having an ankle extension, a heel portion and a foot extension with a closed end, wherein the ankle ulcer sleeve forms a sock enclosing the foot.Docket No.: ITP / 1007PCT

[0049] Figure 9 shows a cross-sectional view of the ankle ulcer sleeve shown in FIG. 7 along line 9-9.

[0050] Figure 10 shows the ankle ulcer sleeve shown in FIG. 9 with an ankle configured therein.

[0051] Figure 11 shows a photograph of an ulcer on a medial side of a person's ankle that was the result of venous insufficiency and the general indications of four ankle perforators, such as Cockett I, Cockett II, and Cockett III perforators.

[0052] Figure 12 shows a photograph of the person’s leg shown in FIG. 11 after treatment including application of an ankle ulcer sleeve over these ankle perforators to reduce and heal the ulcer.

[0053] Figure 13 shows an ankle ulcer sleeve having an ankle extension, a heel portion, a medial compression component with a medial ankle extension and a posterior ankle extension that extend around the medial malleolus and a foot extension with a closed end, wherein the ankle ulcer sleeve forms a sock enclosing the foot.

[0054] Figure 14 shows an ankle ulcer sleeve having an ankle extension, a heel portion and a foot extension with an open end, and a medial compression component with a medial ankle extension and a posterior ankle extension that extend around the medial malleolus and also an anterior medial malleolus portion that extends anterior to the medial malleolus,.

[0055] Figure 15 shows an ankle ulcer sleeve having an ankle extension, a heel portion and a foot extension with a closed end, a medial compression component with a medial ankle extension and a posterior ankle extension that extend around the medial malleolus and also an anterior medial malleolus portion that extends anterior to the medial malleolus.

[0056] Figure 16 shows a cross-sectional view of the ankle ulcer sleeve shown in FIG. 14 along line 16-16.

[0057] Figure 17 shows the ankle ulcer sleeve shown in FIG. 15 along line 17-17 with a person’s lower leg and medial malleolus configured along the medial ankle portion of the ankle extension and along the inside surface of the medial compression component.

[0058] Figure 18 shows a sensor, a manometer, a pressure sensor that measures the pressure produced by the ankle ulcer sleeve and compression component to determine if a sufficient pressure is produced to collapse a vein or perforator.

[0059] Figure 19 shows a perspective view of a portable ultrasound device that has a pressure sensor to enable manual pressure application to determine what pressure is required to effectively collapse a vein.

[0060] Figure 20 shows a portable ultrasound device that with a pressure sensor that is being manually pressed against a person’s ankle to determine what pressure is required to effectively collapse a vein.Docket No.: ITP / 1007PCT

[0061] Figure 21 shows a three dimensional scan rendering of a person’s foot and ankle to enable fabrication of a custom compression component and / or custom ankle ulcer sleeve for effective compression of veins.

[0062] Figure 22 shows a side view of a person’s ankle with a custom fabricated compression component having apertures therethrough.

[0063] Figure 23 shows a side view of a person’s ankle with a custom fabricated ankle ulcer sleeve with a compression portion or component for providing pressure over the perforators.

[0064] Figures 24 shows an end view of a custom fabricated ankle ulcer sleeve with a compression portion or component for providing pressure over the perforators.

[0065] Figure 25 shows a flow diagram of a method to produce a custom compression component and application of said custom compression component to collapse a vein to prevent blood flow therethrough.

[0066] Corresponding reference characters indicate corresponding parts throughout the several views of the figures. The figures represent an illustration of some of the embodiments of the present invention and are not to be construed as limiting the scope of the invention in any manner. Some of the figures may not show all of the features and components of the invention for ease of illustration, but it is to be understood that where possible, features and components from one figure may be included in the other figures. Further, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to employ the present invention.DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0067] As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having" or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Also, use of "a" or "an" are employed to describe elements and components described herein. This is done merely for convenience and to give a general sense of the scope of the invention. This description should be read to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise.

[0068] Certain exemplary embodiments of the present invention are described herein and are illustrated in the accompanying figures. The embodiments described are only for purposes of illustrating the present invention and should not be interpreted as limiting theDocket No.: ITP / 1007PCTscope of the invention. Other embodiments of the invention, and certain modifications, combinations and improvements of the described embodiments, will occur to those skilled in the art and all such alternate embodiments, combinations, modifications, improvements are within the scope of the present invention.

[0069] Figure 1 shows a picture of a person’s ankle with ankle ulcers 102 due to venous insufficiency. The varicose vein 101 produces protrusions on the surface of the sking and poor blood flow also can result in varicose eczema 103 which may be proximal to the medial malleolus 90. The ankle ulcer sleeve as described herein may be configured to collapse veins and perforators to prevent the ankle ulcers and varicose eczema

[0070] Figure 2 shows a diagram of the lower leg, ankle and foot and perforator veins which includes the popliteal vein 110, anterior accessory saphenous vein 111, anterior tibial vein 112, posterior tibial vein 113, perforating vein of the femoral canal 114, paratibial perforating vein 115, posterior accessory saphenous vein 116, posterior tibial perforating vein 117 and medial marginal vein 118. The ankle ulcer sleeve as described herein may be configured to collapse one or more of the veins shown in FIG. 2.

[0071] Figure 3 shows a diagram of the lower leg, ankle and foot and perforator veins including, the saphenofemoral junction 120, Hunterian perforators 121, Dodd's perforators 122, Boyd's perforators 123, 123’ and Cockett's perforators 124, 124’ and 124”. The ankle ulcer sleeve as described herein may be configured to collapse one or more of the veins or perforators shown in FIG. 3 and may extend below the knee or from the knee down below the medial malleolus and collapse the veins and perforators in this region of the lower leg and ankle. The ankle ulcer sleeve may extend along the gaiter region of the lower leg as described herein

[0072] Figure 4 shows a diagram of the lower leg vascular system and ankle perforator veins including the great saphenous vein 140, saphenofemoral junction 141, femoral vein 142, popliteal vein 110, lateral plantar vein 144, medial plantar vein 145, posterior arch vein 146, ankle perforators 147 and Hunter's perforator 148. The ankle ulcer sleeve as described herein may be configured to collapse one or more of the veins or perforators shown in FIG.4.

[0073] Figure 5 shows a person’s foot and ankle and the medial malleolus 90 protruding from the medial side of the ankle. The ankle ulcer sleeve as described herein may be configured to collapse one or more of the veins or perforators shown in FIGS. 2 to 4 and the compression component may extend over these veins and perforators when donned over the ankle and lower leg.

[0074] As shown in FIG. 6, an ankle ulcer sleeve 10 is configured over the ankle and has an ankle extension 20 with a compression component 30, a medial compression component 302, configured along the medial ankle portion 22 of the ankle extension 20. The medialDocket No.: ITP / 1007PCTcompression component 302 extends circumferentially between the anterior ankle portion 24 and the posterior ankle portion 28. The ankle extension 20 has a length from the superior end 25 to the inferior end 27. As shown in FIG. 6, the ankle ulcer sleeve 10 has a first side 21 that is detachably attached to a second side 23 by an attachment component 29, such as hook-and-loop fastener, wherein a first component of the hook-and-loop fastener is configured on the first side and a second component, of the hook-loop-fastener (hook or loop) is configured on the second side of the ankle ulcer sleeve. Note that clips may also be used to secure and detachably attach the first side to the second side. The ankle ulcer sleeve shown in FIG. 6 is a sleeve wrap, however, the ankle ulcer sleeve may be contiguous as shown in FIG. 9, forming a continuous sleeve or sock.

[0075] As shown in FIG. 7, an ankle ulcer sleeve 10 is configured over the ankle, heel and portion of the foot and has an ankle extension 20 with a medial compression component 302 configured along the medial ankle portion 22 of the ankle extension 20. The medial compression component 302 extends circumferentially between an anterior ankle portion 24 and posterior ankle portion 28. The ankle extension 20 has a length from the superior end 25 to the heel portion 50 that extends over the heel. The foot extension 60 extends from the heel portion 50 to foot end 62, an open end 66.

[0076] As shown in FIG. 8, an ankle ulcer sleeve 10 is configured over the ankle, heel and portion of the foot and has an ankle extension 20 with a medial compression component 302 configured along the medial ankle portion 22 of the ankle extension 20. The medial compression component 302 extends circumferentially between an anterior ankle portion 24 and posterior ankle portion 28. The ankle extension 20 has a length from the superior end 25 to the heel portion 50 that extends over the heel. The foot extension 60 extends from the heel portion 50 to foot end 62, that is a closed end 68 of the ankle ulcer sleeve 10.

[0077] The medial compression component 302 shown in FIGS. 6, 7 and 8 is shown in broken lines as it extends along an interior of the ankle extension 20. Note that fabric may extend over the compression component along an interior surface of the ankle extension for comfort, however.

[0078] As shown in FIG. 9, ankle ulcer sleeve 10 has a medial compression component 302, such as an elastomeric material 35 extending circumferentially along the medial ankle portion 22 and between the anterior ankle portion 24 and posterior ankle portion 28. The ankle extension 20 may be a fabric 31, a woven fabric that is elastic and can be expanded radially. The ankle extension 20 forms a sleeve having an anterior ankle portion 24, posterior ankle portion 28, medial ankle portion 22 and lateral ankle portion 26, opposite the medial ankle portion 22, as indicated by the curved double arrowed lines around the ankle ulcer sleeve 10. Also, in some cases, an ankle ulcer sleeve 10 may include a lateral compression component 306, that may also be an elastomeric material extending on aDocket No.: ITP / 1007PCTlateral inside surface of the ankle extension circumferentially along the lateral ankle portion 28 and between the anterior ankle portion 24 and posterior ankle portion 28.

[0079] Referring now to FIGS. 9 and 10, the thickness of the compression component may vary along the contact surface 301 when donned over a person’s ankle, and this contact surface may be contoured to produce increased pressure on the veins and perforators and may have a contoured surface configured to match the general anatomic contours around the medial malleolus. Also, as described herein, the compression component may be fabricated to match the shape, curvature and contours of a person’s anatomy and the inside surface of the medial compression component may match the curvature around the medial malleolus and may be concave in shape. Also, when a lateral compression component is incorporated, the contact surface 301’ of the lateral compression component 306 may match the curvature around the lateral malleolus and may have a concave shape. A medial compression component 302 may extend on the medial side of the ankle extension 20, or along the medial ankle portion 22. A medial compression component 302 may extend around the medial malleolus and may have a medial malleolus recess 303, a portion of the medial compression component that is much thinner than a posterior portion 308 and / or anterior portion 304 of the medial compression component, such as less than 75% of the thickness, less than 50% of the thickness or even less than 25% of the thickness of the posterior portion and / or anterior portion of the medial compression component. The medial malleolus recess may be concave in shape to conform over the medial malleolus. A medial or lateral malleolus recess may be an aperture of form an aperture in the respective compression component for locating the compression component over the protrusion of the medial or lateral malleolus, respectively.

[0080] Likewise, a lateral compression component 306 may extend on the lateral side of the ankle extension 20, or along the lateral ankle portion 26 and may also have a thickness that varies and may have a lateral malleolus recess 307, a portion of the lateral compression component that is much thinner than a posterior portion 308’ and / or anterior portion 304’ of the lateral compression component, such as less than 75% of the thickness, less than 50% of the thickness or even less than 25% of the thickness of the posterior portion and / or anterior portion of the medial compression component. A lateral malleolus recess 307 may be concave in shape to conform to the lateral malleolus.

[0081] The medial and / or lateral compression components may include protrusions 311 that extend from the contact surface 301, 301’, respectively and these protrusions may allow airflow to the skin and tissue to reduce heat and prevent necrosis of the skin under the compression component. Also, medial and / or lateral compression components may include apertures 312 that extend through the thickness of the compression component to enable airflow to the skin. The medial and lateral compression components may include strandsDocket No.: ITP / 1007PCT314 that are interconnect at nodes, as shown in FIG. 22 and may be fabricated by molding or three-dimensional printing to match a measured shape of the anatomy of a person’s ankle.

[0082] As shown in FIG. 10, the medial compression component 302 conforms around the medial malleolus 90 with the medial malleolus recess 303 configured or aligned over the medial malleolus 90 and the lateral compression component 306 conforms around the lateral malleolus with the lateral malleolus recess 307 configured or aligned over the lateral malleolus 92. Note that medial compression component may have a medial malleolus aperture 310 or opening for locating the medial compression component around the medial malleolus 90 and likewise the lateral compression component may have a lateral malleolus aperture or opening in the lateral compression component for locating the lateral compression component around the lateral malleolus.

[0083] Figure 11 shows a photograph of an ulcer 80 on a medial side 88 of a person’s ankle from venous insufficiency and the general indications of three ankle perforators 81, 82 and 83. As described herein, ankle perforators may include Cockett perforators including Cockett I, Cockett II and Cockett III perforators.

[0084] Figure 12 shows a photograph of the person’s leg shown in FIG 11 after treatment including application of an ankle ulcer sleeve over these ankle perforators to reduce and heal the ulcer.

[0085] Referring now to FIGS. 13 to 16, an ankle ulcer sleeve 10 has an ankle extension 20, a heel portion 50, a foot extension 60 and a compression component 30, a medial compression component 302 with a medial ankle extension 32 and a posterior ankle extension 38 that extends around the medial malleolus 90. The medial ankle extension 32 and a posterior ankle extension 38 are connected along a connected portion 37 that is on a posterior side of the medial malleolus 90. As shown in FIG. 13, the medial compression component 302 is L-shaped. The compression component may have a curved edge along the anterior side of the connected portion 37 for conforming around the medial malleolus protrusion, as shown in FIG. 13. The foot extension 60 has foot end 62 that is an open end 66 as shown in FIG. 14. As shown in FIGS 13 and 15, the foot extension 60 has foot end 62, that is a closed end 68.

[0086] As shown in FIG. 13, the posterior ankle extension 38 has a length 34 extending along a length axis 380 from the connected portion 37 to an extended end 36, or the superior edge of the compression component, and a width 39 that may enlarge along the posterior ankle extension toward the extended end. The medial ankle extension 32 has a length 40 extending along a length axis 320 from the connected end to an extended end 41. As described herein the length of the posterior ankle extension 38 may be about 10cm or more, about 15cm or more, about 20cm or more, about 30cm or more and any rangeDocket No.: ITP / 1007PCTbetween and including the values provided. The width 39 of the posterior ankle extension 38 may be a fraction of the length, such as about 0.75 the length or less, about 0.5 the length or less. Also, the width of the posterior ankle extension 38 may be about 2cm or more, about 2.5cm or more, about 3.0cm or more, about 4cm or more, about 5cm or more, about 6cm or more and any range between and including the width values provided. Also, the width may change along the length of the posterior ankle extension 38 and may increase from a connected portion 37 to the extended end 36. As shown in FIG. 15, the width of the posterior ankle extension at the extended end 36 or proximal to the extended end 36 or superior edge 361 is much greater than the width 39’ proximal of the connected portion 37, such as about 1.5 times or more, about 1.75 times or more, about 2.0 times or more and any range between and including the ratios provided. The posterior ankle extension widens toward the extended end. This geometry of the posterior ankle extension 38 may provide better compression over some of the perforators. As described herein, the vast majority of perforators on the medial side of the ankle and lower leg that require compression to prevent ulcers are located within about 4cm posterior of the medial malleolus and 20cm above the medial malleolus.

[0087] The medial ankle extension 32 has a length 40 from the connected portion 37 to an extended end 41 that may be about 10cm or more, about 8cm or more, about 6cm or more, about 4cm or more and any range between and including the values provided and a width 33 that may be about 8cm or more, about 6cm or more, about 4cm or more, about 2cm or more and any range between and including the values provided. Also, the width of the medial ankle extension 32 may be about 2cm or more, about 2.5cm or more, about 3.0cm or more, about 3.5cm or more, about 4cm or more, about 5cm or more and any range between and including the width values provided. The medial ankle extension 32 and a posterior ankle extension 38 are connected along a connected portion 37 that is on a posterior side of the medial malleolus 90. The medial compression component 302 has a curved edge along the anterior side of the connected portion 37 that conforms around the protrusion of the medial malleolus 90 protrusion and may better retain the ankle ulcer sleeve in position and provide improved compression over the perforators to prevent ankle ulcers

[0088] As shown in FIGS. 14 and 15, the compression component 30, a medial compression component 302 has a medial ankle extension 32 and a posterior ankle extension 38 and an anterior portion 304, configured anterior to the medial malleolus, such that the medial compression component extends over and / or around the medial malleolus 90. As shown in FIG. 14 the medial compression component has a medial malleolus aperture 310 for locating the ankle ulcer sleeve on a person’s ankle with the medial compression component configured properly around the medial malleolus. This may be important to ensure proper compression for collapsing veins and perforators. As shown inDocket No.: ITP / 1007PCTFIG. 15 the medial compression component 302 has a medial malleolus recess 307, that may be concave in shape for alignment over the medial malleolus.

[0089] Referring now to FIGS. 16 and 17, the medial ankle extension has protrusions 311, along an inside surface to allow airflow along the compression component. The protrusions extend over the entire inside surface of the compression component. Also, the protrusions may be elongated having a length that is at least three times a width. Protrusions may be aligned with each other, such as parallel with each other to form channels and these may be straight channels or have some curvature. An elongated protrusion may extend from a first edge to a second edge of the compression component, such as from a superior edge 361 to an inferior edge 362 as indicated by the dashed lines in FIG 14. The width of a protrusion may be about 2mm or more, about 4mm or more about 6mm or more, or even about 10mm or more, and any range between and including the width values provided. The length of an elongate protrusion may be the length or the width of the compression components, as described herein, or may be shorter than the length or width or the compression components. The height of the protrusion may be about 1mm or more, 2mm or more, 3mm or more, 4mm or more or even 5mm or more. The height and width may change along the length of an elongated protrusion

[0090] The thickness 45 of the medial compression component 302 is shown in FIG. 16 varies from one location to another location of the compression component to produce a contoured contact surface 301 to match the contour of an ankle. As shown in FIG. 16, the medial compression component has a medial malleolus aperture 310 for extending over the medial malleolus when donned. The thickness may increase toward an inferior region of the compression component at least along the posterior ankle extension. This may push blood up the leg to prevent pooling along an inferior region of the ankle. The lower leg 84 and ankle 85 are shown in FIG. 17. As shown, the medial malleolus recess 303 conforms around the medial malleolus 90.

[0091] Figure 18 shows a sensor, a manometer, a pressure sensor 71 that measures the pressure produced by the ankle ulcer sleeve 10 and compression component, which may be used to determine if a required pressure is achieved to collapse a vein or perforator when the ankle ulcer sleeve as described herein is donned. The pressure measure by donning the ankle ulcer sleeve may be compared with a prior pressure measured to collapse a vein or perforator, as shown in FIG. 20.

[0092] Figure 19 shows a perspective view of a portable ultrasound pressure device 78 that has a pressure sensor 70 and an ultrasound device 76 to enable manual pressure application to determine what pressure is required to effectively collapse a vein or perforator. The head of the pressure sensor may be blunt or planar and the pressure may be calculated as the force applied divided by the surface area of the pressure head.Docket No.: ITP / 1007PCT

[0093] Figure 20 shows a portable ultrasound pressure device 78 with a pressure sensor that is being manually pressed against a person’s ankle to determine what pressure is required to effectively collapse a vein. The ultrasound may produce an image on a screen to indicate when the vein or perforator is effectively collapses to block blood flow therethrough.

[0094] Figure 21 shows a three dimensional scan rendering of a person’s foot and ankle to enable fabrication of a custom compression component and / or custom ankle ulcer sleeve for effective compression of veins. Three dimension scanning may be accomplished through light or laser scans to produce a three-dimensional model of the lower leg, ankle and foot.

[0095] Referring now to FIGS. 22 to 24, a compression component 30, such as the medial compression component 302, as shown, may be a custom compression component having geometry that is complimentary to the contours of a person's ankle, which may be determined through a scan of the person’s ankle, as shown in FIG. 21. As shown in FIG. 22, the custom compression component 30 may include apertures 312 therethrough to enable oxygen exchange with the person’s skin and prevent excessive heat between the compression component and the person’s skin. The compression component may include strands 314, such as elongated strands that are interconnected by nodes, forming a lattice. A compression component may include strands that can form thicker portions and thinner portions of the compression component to conform to the geometry of the ankle. Also, the strand may be wider or more narrow for mechanical benefits and may have apertures between the strands to enable airflow therethrough. The compression component formed by strands may be formed through 3-dimensional printing, for example which may enable custom geometries to be formed after determination of the curvature of a person's ankle, such as by 3-dimenional scanning. Again, the lattice of the compression component may be integrally integrated into the ankle extension, wherein the ankle extension and the compression component are a one piece component.

[0096] As shown in FIG. 23, the compression component 30, the medial compression component 302, may be attached to or integrally formed with the ankle ulcer sleeve 10. Also, the compression component may include an anterior portion 304 that is anterior to the medial malleolus 90. Also, the medial compression component 302 includes a posterior portion 308 and a posterior ankle extension 38 that extends posterior to the medial malleolus 90.

[0097] As shown in FIG. 24, the ankle ulcer sleeve 10 includes a compression component 30 that extends inward along the interior surface 230 and has a contoured thickness to produce a contact surface 301 that conforms with the contours of a person’s ankle. Again, the ankle ulcer sleeve 10 shown in FIG. 23 and 24, may be a custom ankle ulcer sleeve that includes a compression component 30 that has a geometry including thickness contours that match contours of a person’s ankle, such as around the medial malleolus 90.Docket No.: ITP / 1007PCT

[0098] As shown in FIG. 25, a method to produce a custom compression component and / or a custom ankle ulcer sleeve includes measuring the pressure required to effectively collapse a vein. The method further includes scanning the person’s ankle to determine the geometry of the person’s ankle. A custom compression component and / or ankle ulcer sleeve can then be fabricated, such as through three-dimensional printing to have specific complimentary geometry to conform with the person’s ankle geometry determined through the scan.Finally, the method includes applying the ankle ulcer sleeve and compression component over the person’s ankle to collapse a vein and prevent blood flow through the vein. As shown in FIG. 17, a manometer or other pressure sensor may be used to measure the pressure applied by the ankle ulcer sleeve to ensure that the pressure applied is sufficient to collapse the vein or perforators.

[0099] It will be apparent to those skilled in the art that various modifications, combinations and variations can be made in the present invention without departing from the scope of the invention. Specific embodiments, features and elements described herein may be modified, and / or combined in any suitable manner. Thus, it is intended that the present invention cover the modifications, combinations and variations of this invention provided they come within the scope of the appended claims and their equivalents

Claims

What is claimed is:

1. An ankle ulcer sleeve comprising:a) ankle extension that is configured to extend over an ankle of a person and comprising:i) a length from an inferior end to a superior end;ii) a lateral ankle portion;iii) a medial ankle portion;iv) an anterior ankle portion; andv) a posterior ankle portion;b) a medial compression component extending along the medial ankle portion of the ankle extension;wherein the compression component has a thickness that is at least 50% greater than the ankle extension; andwherein the ankle extension is radially elastic.

2. The ankle ulcer sleeve of claim 1, having a radial compression pressure at 20% radial extension of at least 20mm Hg.

3. The ankle ulcer sleeve of claim 1, having a radial compression pressure at 20% radial extension of at least 30mm Hg.

4. The ankle ulcer sleeve of claim 1, wherein the medial compression component extends only along the medial ankle portion.

5. The ankle ulcer sleeve of claim 1, wherein the medial compression component extends no more than 30% of an inner circumference of the ankle extension.

6. The ankle ulcer sleeve of claim 1, wherein the medial compression component comprises an elastomeric material.

7. The ankle ulcer sleeve of claim 6, wherein the elastomeric material is silicone.

8. The ankle ulcer sleeve of claim 6, wherein the elastomeric material is polyurethane.

9. The ankle ulcer sleeve of claim 6, having a radial compression pressure at 20% radial extension of at least 20mm Hg.

10. The ankle ulcer sleeve of claim 6, having a radial compression pressure at 20% radial extension of at least 30mm Hg.

11. The ankle ulcer sleeve of claim 6, wherein the medial compression component of has a thickness that is at least 100% greater than the ankle extension on an anterior ankle portion.

12. The ankle ulcer sleeve of claim 1, wherein the ankle extension comprises a woven fabric.

13. The ankle ulcer sleeve of claim 1, wherein the length of the ankle extension is no more than 35cm.

14. The ankle ulcer sleeve of claim 1, wherein the length of the medial compression component extends at least 75% of the length of the ankle extension.

15. The ankle ulcer sleeve of claim 1, wherein the length of the ankle extension is no more than 25cm.

16. The ankle ulcer sleeve of claim 1, wherein the length of the medial compression component extends at least 75% of the length of the ankle extension.

17. The ankle ulcer sleeve of claim 1, wherein when the ankle ulcer sleeve is donned over a person’s ankle, the medial compression component comprises a posterior ankle extension configured to extend posterior to said medial malleolus and toward the superior end of the ankle extension.

18. The ankle ulcer sleeve of claim 17, wherein the posterior ankle extension has a length of at least 10cm and a width of at least 4cm.

19. The ankle ulcer sleeve of claim 18, wherein a width of the posterior ankle extension increases toward the superior end of the ankle extension.

20. The ankle ulcer sleeve of claim 18, wherein when the ankle ulcer sleeve is donned over a person’s ankle, the medial compression component is configured to extend around a medial malleolus and further comprises a medial ankle extension that extends on an inferior side of the medial malleolus from the posterior ankle extension toward the anterior ankle portion and wherein the medial ankle extension and posterior ankle extensions are joined in a connected portion.

21. The ankle ulcer sleeve of claim 20, wherein the medial ankle extension and posterior ankle extension are a contiguous part having a connected portion configured for location posterior the medial malleolus when the ankle ulcer sleeve is donned over an ankle.

22. The ankle ulcer sleeve of claim 21, wherein a length axis of the posterior ankle extension extends substantially orthogonal to a length axis of the medial ankle extension within about 20 degrees of orthogonal.

23. The ankle ulcer sleeve of claim 21, wherein when the medial ankle extension has a length of 6cm or more.

24. The ankle ulcer sleeve of claim 21, wherein when the ankle ulcer sleeve is donned over a person’s ankle, the medial compression component is configured to extend around a medial malleolus and has an anterior portion configured to extend on an anterior side of the medial malleolus opposite the posterior ankle extension.

25. The ankle ulcer sleeve of claim 24, wherein the medial compression component further comprises a medial malleolus recess that is configured to extend over the medial malleolus.

26. The ankle ulcer sleeve of claim 25, wherein a thickness of the medial compression component along the medial malleolus recess is less than 75% of the thickness of the posterior ankle extension of the medial compression component.

27. The ankle ulcer sleeve of claim 25, wherein the medial malleolus recess is a concave recess.

28. The ankle ulcer sleeve of claim 27, wherein the medial malleolus recess forms a medial malleolus aperture that is configured to extend over the medial malleolus.

29. The ankle ulcer sleeve of claim 1, wherein when the ankle ulcer sleeve is donned over a person’s ankle, the medial compression component is configured to extend around a medial malleolus and has an anterior portion configured to extend on an anterior side of the medial malleolus and a posterior portion configured to extend on a posterior side of the medial malleolus.

30. The ankle ulcer sleeve of claim 29, wherein the medial compression component further comprises a medial malleolus recess that is configured to extend over the medial malleolus.

31. The ankle ulcer sleeve of claim 30, wherein a thickness of the medial compression component along the medial malleolus recess is less than 75% of the thickness of the posterior portion of the medial compression component.

32. The ankle ulcer sleeve of claim 30, wherein the medial malleolus recess is a concave recess.

33. The ankle ulcer sleeve of claim 30, wherein the medial malleolus recess form a medial malleolus aperture that is configured to extend over the medial malleolus.

34. The ankle ulcer sleeve of any one of claims 1 to 33, wherein the medial compression component further comprises protrusions on an inside surface of the medial compression component.

35. The ankle ulcer sleeve of claim 34, wherein the protrusions are discrete protrusions.

36. The ankle ulcer sleeve of claim 35, wherein the protrusions are elongated protrusions having a length at least three times a width.

37. The ankle ulcer sleeve of claim 36, wherein the elongated protrusions extend from a first edge to an opposing second edge of the medial compression component.

38. The ankle ulcer sleeve of claim 36, wherein the elongated protrusions extend vertically when donned from a superior edge to an inferior edge of the medial compression component.

39. The ankle ulcer sleeve of any one of claims 1 to 33, wherein the medial compression component has apertures that extend through the medial compression component.

40. The ankle ulcer sleeve of any one of claims 1 to 33, wherein the medial compression component is an elastomeric material.

41. The ankle ulcer sleeve of any one of claims 1 to 33, wherein the medial compression component is a three-dimensional printed compression component.

42. The ankle ulcer sleeve of any one of claims 1 to 33, wherein the medial compression component and the ankle extension of the ankle ulcer sleeve are a three-dimensional printed compression component, wherein the medial compression component is integral with the ankle extension.

43. The ankle ulcer sleeve of any one of claims 1 to 33, wherein the ankle ulcer sleeve has only the medial compression component on the medial ankle portion of the ankle sleeve that is a contiguous component.

44. The ankle ulcer sleeve of any one of claims 1 to 33, further comprising a lateral compression component extending along the lateral ankle portion of the ankle extension;wherein the lateral compression component has a thickness that is at least 50% greater than the ankle extension.

45. The ankle ulcer sleeve of claim 44, wherein when the ankle ulcer sleeve is donned over a person’s ankle, the lateral compression component is configured to extend around a lateral malleolus and has an anterior portion configured to extend on an anterior side of the lateral malleolus and a posterior portion configured to extend on a posterior side of the lateral malleolus.

46. The ankle ulcer sleeve of claim 45, wherein the lateral compression component further comprises a lateral malleolus recess that is configured to extend over the lateral malleolus.

47. The ankle ulcer sleeve of claim 46, wherein the lateral malleolus recess forms a lateral malleolus aperture configured to extend over the lateral malleolus.

48. The ankle ulcer sleeve of claim 46, wherein a thickness of the lateral compression component along the lateral malleolus recess is less than 75% of the thickness of the posterior portion of the lateral compression component.

49. The ankle ulcer sleeve of claim 46, wherein a thickness of the lateral compression component along the lateral malleolus recess is less than 50% of the thickness of the posterior portion of the lateral compression component.

50. A method of making an ankle ulcer sleeve comprising:a) scanning a person's ankle to determine an ankle geometry; andb) fabricating said ankle ulcer sleeve as described in any one of claim 1 to 33, wherein the medial compression component has a compression geometry that conforms to said ankle geometry.

51. The method of claim 50, further comprising attaching the medial compression component to the ankle ulcer sleeve.

52. The method of claim 50, wherein the medial compression component is an integral part of the ankle ulcer sleeve.

53. The method of claim 50, wherein the compression component is an elastomer.

54. The method of claim 50, wherein the fabricating said ankle ulcer sleeve comprises three- dimensional printing the medial compression component.

55. The method of claim 54, wherein the medial compression component comprises strands of elastomeric material that are connected at nodes.

56. The method of claim 55, wherein the medial compression component comprises apertures.

57. The method of claim 55, wherein the medial the apertures are configured between the strands.

58. A method of compressing a perforator in a person’s ankle comprising:a) measuring a collapsing pressure that is a pressure required to block blood flow through said perforator;b) fabricating an ankle ulcer sleeve with a compression component that exerts said collapsing pressure; andc) donning the ankle ulcer sleeve with the compression component configured over the perforator.

59. The method of claim 58, wherein fabricating the ankle ulcer sleeve comprises:a) scanning a person’s ankle to determine an ankle geometry;b) fabricating said compression component having a compression geometry that conforms to said ankle geometry.

60. The method of claim 59, further comprising attaching the compression component to the ankle ulcer sleeve.

61. The method of claim 59, wherein the compression component is an integral part of the ankle ulcer sleeve.

62. The method of claim 59, wherein the compression component is an elastomer.

63. The method of any one of claims 58 to 62, wherein the compression component is a three-dimensional compression component having curvature along an inside surface of the compression component.

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